Clinical Validation Trial of a Single-use Bronchoscope (Ambu® aScope ™ 4)

Clinical Validation Trial of the Single-use Bronchoscope Ambu® aScope ™ 4

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03419546

Enrollment

216

Registered

2018-02-05

Start date

2018-03-01

Completion date

2018-08-31

Last updated

2018-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchoscopy

Brief summary

The aim of this study is to evaluate the usefulness of the new Ambu® aScope ™ 4 bronchoscope, in the usual practice of low complexity diagnostic bronchoscopy managed by bronchoscopists who meet the minimum training requirements (having performed 100 supervised procedures \[ 10\]) and maintenance of competition (with more than 25 bronchoscopies per year \[10\]).

Detailed description

Muticentric trial to evaluate three outcomes 1. Describe the experience of bronchoscopists performing low complexity bronchoscopic procedures with the Ambu® aScope ™ 4. 2. Collect the opinion of bronchoscopists about the technical characteristics of the device subject to study through a standardized questionnaire. 3. Analyze the quality of both microbiological and cytological samples obtained through the disposable bronchoscope.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Low complexity bronchoscopies in patients that need to undergo a low complexity bronchoscopy in the sites of the study

Exclusion criteria

* No acceptance of the informed consent * Any procedure out of a low complexity bronchoscopy in the sites of the study

Design outcomes

Primary

Measure	Time frame	Description
Bronchoscope Quality questionnaire evaluation	Feb 2018- july 2018	\- A numeric scale describes the experience of bronchoscopists performing low complexity bronchoscopic procedures with the Ambu® aScope ™ 4.

Secondary

Measure	Time frame	Description
-Opinion of the operator -Quality of the sample	Feb 2018 -july 2018	1.A numeric scale collects the opinion of bronchoscopists about the technical characteristics of the device subject to study through a standardized questionnaire.
- Sample quality	Feb 2018- july 2018	2.Analyze the quality of both microbiological and cytological samples obtained through the disposable bronchoscope describing the diagnostic yield.

Countries

Spain

Outcome results